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Motivational Interviewing in Thoracic Outlet Syndrome

15 września 2026 zaktualizowane przez: Tüzün Fırat, Hacettepe University

The Effect of Motivational Interviewing on Thoracic Outlet Syndrome Symptoms in Patients With Thoracic Outlet Syndrome

The goal of this clinical trial is to learn if motivational interviewing (MI) works to improve symptoms in people with thoracic outlet syndrome (TOS). TOS is a condition that causes long-term pain, numbness, and weakness in the arm and shoulder area. The main questions it aims to answer are:

  • Does MI lower pain and improve arm function in people with TOS?
  • Does psychological resilience predict treatment outcomes in people with TOS? Researchers will compare participants who receive MI sessions plus a home exercise program to those who receive a home exercise program alone. Participants will be randomly assigned to one of the two groups.

Participants will:

  • Follow a home exercise program for 6 weeks
  • Some participants will also attend up to 4 motivational interviewing sessions
  • Complete questionnaires about pain, function, sleep, anxiety, and depression at the start and end of the 6-week program

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a single-center, non-blinded (assessor-blinded), parallel-group study examining the effect of motivational interviewing (MI) as an adjunct to a standardized home exercise program in patients with thoracic outlet syndrome (TOS). Eligible participants are randomly assigned using block randomization (block size of 4) to either the experimental arm (home exercise plus MI) or the active comparator arm (home exercise alone). The randomization sequence is generated using an online randomization tool by an individual not otherwise involved in the study, ensuring allocation concealment.

MI sessions are structured around four core techniques: open-ended questioning, affirmations, reflective listening, and summarizing. Sessions proceed through engagement, agenda setting, evocation of change talk, and goal setting phases, using strategies such as exploring ambivalence, decisional balance exercises, and scaling questions to assess motivation and confidence for behavior change. Homework assignments tailored to each participant's goals may include relaxation exercises, breath awareness training, and emotion regulation strategies in addition to the standard home exercise program.

All outcome assessments are conducted by a physiotherapist who is blinded to group allocation and not otherwise involved in delivering the interventions. Assessments take place at baseline (prior to initiation of the home exercise program) and at week 6.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

70

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Turcja (Türkiye)
      • Ankara, Turcja (Türkiye)
        • Rekrutacyjny
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation
        • Kontakt:
        • Główny śledczy:
          • Tüzün Fırat, Prof
        • Pod-śledczy:
          • Nur Sena Yarımkaya, MSc, PT, Psychologist
        • Pod-śledczy:
          • Gülay Uzun, MSc, PT
        • Pod-śledczy:
          • Ayten Kayı Cangır, Prof
        • Pod-śledczy:
          • Şule T Tüzen Tek, MSc, PT

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Diagnosis of thoracic outlet syndrome
  • Age between 18 and 65 years
  • Pain duration of more than 6 months
  • No surgical intervention in the last 6 months

Exclusion Criteria:

  • Accompanying pathologies (cervical disc problems, fibromyalgia, rotator cuff problems, diabetes, neoplastic processes)
  • Unwillingness to provide informed consent

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Motivational Interviewing + Home Exercise
Participants randomly assigned to this arm receive a standardized 6-week home exercise program in addition to up to 4 face-to-face motivational interviewing (MI) sessions. The first two MI sessions are conducted one week apart, and the remaining two sessions two weeks apart, completing all 4 sessions within 6 weeks. MI sessions are delivered by a physiotherapist and a clinical psychologist trained in motivational interviewing techniques, and address ambivalence, goal setting, and behavior change related to pain management and adherence to the exercise program. The home exercise program is taught face-to-face by a physiotherapist and includes scalene and upper trapezius stretching, pectoralis minor stretching, median and ulnar nerve mobilization exercises, scapular stabilization exercises (middle/lower trapezius and rhomboids), and diaphragmatic breathing training, to be performed 3 times daily, 10 repetitions per sessio
Behawioralne: Motivational Interviewing
A patient-centered counseling approach consisting of up to 4 face-to-face sessions delivered over 6 weeks. Sessions follow motivational interviewing (MI) principles, including collaborative engagement, open-ended questions, reflective listening, affirmations, and summarizing, to explore ambivalence and elicit change talk. Sessions address goal setting, decisional balance regarding behavior change, and strategies to support adherence to pain self-management and the home exercise program.
Behawioralne: Home Exercise Program
A standardized 6-week home exercise program taught face-to-face by a physiotherapist, including scalene and upper trapezius stretching (15 seconds per repetition), pectoralis minor stretching (15 seconds per repetition), median and ulnar nerve self-mobilization exercises, scapular stabilization exercises targeting the middle and lower trapezius and rhomboid muscles using elastic resistance bands, and diaphragmatic breathing training. The program is performed 3 times daily, 10 repetitions per exercise, for 6 weeks. Participants maintain an exercise diary to track adherence.
Aktywny komparator: Home Exercise Only
Participants randomly assigned to this arm receive the same standardized 6-week home exercise program as the experimental arm, without motivational interviewing sessions. The home exercise program is taught face-to-face by a physiotherapist and includes scalene and upper trapezius stretching, pectoralis minor stretching, median and ulnar nerve mobilization exercises, scapular stabilization exercises (middle/lower trapezius and rhomboids), and diaphragmatic breathing training, to be performed 3 times daily, 10 repetitions per session, for 6 weeks.
Behawioralne: Home Exercise Program
A standardized 6-week home exercise program taught face-to-face by a physiotherapist, including scalene and upper trapezius stretching (15 seconds per repetition), pectoralis minor stretching (15 seconds per repetition), median and ulnar nerve self-mobilization exercises, scapular stabilization exercises targeting the middle and lower trapezius and rhomboid muscles using elastic resistance bands, and diaphragmatic breathing training. The program is performed 3 times daily, 10 repetitions per exercise, for 6 weeks. Participants maintain an exercise diary to track adherence.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pain Intensity (Visual Analog Scale)
Ramy czasowe: 6 weeks
Pain intensity assessed using a 10 cm Visual Analog Scale (VAS), separately for pain at rest, during activity, and at night. Scores range from 0 (no pain) to 10 (unbearable pain). Higher scores indicate greater pain intensity.
6 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Upper Extremity Function (DASH Questionnaire)
Ramy czasowe: 6 weeks
Upper extremity function and symptoms assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, a 30-item scale covering daily activities, symptoms, and social/work/sleep impact. Scores are transformed to range from 0 to 100. Higher scores indicate greater disability.
6 weeks
Central Sensitization (Central Sensitization Inventory)
Ramy czasowe: 6 weeks
Central sensitization-related symptoms assessed using Part A of the Central Sensitization Inventory (CSI), a 25-item questionnaire with each item scored from 0 (never) to 4 (always). Total scores range from 0 to 100. Higher scores indicate greater central sensitization. A cut-off score of 40 or above is widely used to indicate clinically significant central sensitization, with severity classified as subclinical (0-29), mild (30-39), moderate (40-49), severe (50-59), or extreme (60-100).
6 weeks
Kinesiophobia (Tampa Scale of Kinesiophobia)
Ramy czasowe: 6 weeks
Fear of movement and re-injury assessed using the Tampa Scale of Kinesiophobia (TSK), a 17-item questionnaire with each item scored from 1 (strongly disagree) to 4 (strongly agree). Total scores range from 17 to 68. Higher scores indicate greater kinesiophobia.
6 weeks
Depression, Anxiety and Stress (DASS-21)
Ramy czasowe: 6 weeks
Depression, anxiety, and stress symptoms assessed using the Depression Anxiety Stress Scale-21 (DASS-21), a 21-item scale with 7 items per subscale (Depression, Anxiety, Stress), each item scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Subscale raw scores are summed and multiplied by 2 to allow comparison with normative data from the original 42-item DASS. Higher scores indicate greater severity. Severity is classified using standard cut-offs: Depression (Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+), Anxiety (Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+), and Stress (Normal 0-14, Mild 15-18, Moderate 19-25, Severe 26-33, Extremely Severe 34+).
6 weeks
Psychological Resilience (Brief Resilience Scale)
Ramy czasowe: 6 weeks
Psychological resilience assessed using the Brief Resilience Scale (BRS), a 6-item scale with each item scored from 1 (strongly disagree) to 5 (strongly agree); 3 items are reverse-scored. Total scores range from 1.00 to 5.00. Scores are classified as low (1.00-2.99), normal (3.00-4.30), or high (4.31-5.00) resilience.
6 weeks
Pain Self-Efficacy (Pain Self-Efficacy Questionnaire)
Ramy czasowe: 6 weeks
Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ), a 10-item scale with each item scored from 0 (not at all confident) to 6 (completely confident). Total scores range from 0 to 60. Higher scores indicate greater pain self-efficacy.
6 weeks
Pain Coping (Pain Coping Inventory)
Ramy czasowe: 6 weeks
Pain coping strategies assessed using the Pain Coping Inventory (PCI), a 22-item scale covering 6 subscales of active coping (distraction, pain transformation, reducing demands) and passive coping (worrying, resting, retreating). Each item is scored from 1 (rarely or never) to 4 (very often). Higher subscale scores indicate greater use of that coping strategy. There is no universally established cut-off value; subscale scores are interpreted continuously.
6 weeks
Sleep Quality (Jenkins Sleep Scale)
Ramy czasowe: 6 weeks
Sleep disturbance assessed using the Jenkins Sleep Scale, a 4-item questionnaire with each item scored from 0 (not at all) to 5 (22-28 nights). Total scores range from 0 to 20. Higher scores indicate greater sleep disturbance.
6 weeks
Anxiety (State-Trait Anxiety Inventory)
Ramy czasowe: 6 weeks
State and trait anxiety assessed using the State-Trait Anxiety Inventory (STAI), a 40-item scale (20 items per subscale) with each item scored from 1 to 4. Subscale scores range from 20 to 80. Higher scores indicate greater anxiety. There is no universally established cut-off value; scores are interpreted continuously.
6 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hacettepe University

Śledczy

  • Główny śledczy: Tüzün Fırat, Prof, Hacettepe University Faculty of Physical Therapy and Rehabilitation

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 października 2027

Ukończenie studiów (Szacowany)

1 października 2027

Daty rejestracji na studia

Pierwszy przesłany

19 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

25 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 września 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FTREK26/38 (Inny identyfikator: Hacettepe University Faculty of Physical Therapy and Rehabilitation Research Ethics Committee)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared due to ethical and privacy considerations related to the sensitive nature of the psychological and pain-related data collected, and because no data sharing infrastructure or participant consent for external data sharing was established for this study.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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